M. Riyaz Hashmi
India’s drug regulator, the Central Drugs Standard Control Organisation (CDSCO), has adopted a stricter approach towards the approval of new drugs linked to nearly 40 million patients in the country. During separate meetings of various Subject Expert Committees (SECs) held in July, experts made it clear that approvals granted in the United States or Europe alone would not be sufficient for marketing new drugs in India. Wherever necessary, companies will have to submit additional clinical data from Indian patients, safety studies, and other scientific evidence before receiving regulatory clearance.
The most significant decision concerned AstraZeneca’s new anti-hypertensive drug Baxdrostat. While the company informed the committee that the drug had already been approved in the United States, the experts observed that the available clinical data on Indian patients was insufficient. Citing concerns over potential serious adverse effects, the committee sought additional clinical data from Indian patients and did not recommend approval at this stage.
In another key decision, the committee recommended granting a waiver from conducting a local Phase III clinical trialfor Johnson & Johnson’s blood cancer (multiple myeloma) therapy Darzalex Faspro. However, it imposed a condition that the company must conduct a Phase IV study in India to assess the drug’s safety and effectiveness after marketing approval, and submit the study protocol to CDSCO within three months.
Similarly, Alkem Laboratories’ Gabapentin Extended Release 200 mg tablets, indicated for conditions such as neuropathic (nerve) pain, were also denied immediate approval. The committee noted that the 200 mg strength has not been approved in any country worldwide. It directed the company to first conduct a bioavailability study—to determine how much and how quickly the drug is absorbed and becomes effective in the body—and submit the study protocol to the drug regulator for further review.
Scientific Evidence Takes Priority Over Big-Name Approvals
The decisions taken by the three different expert committees indicate that CDSCO is placing greater emphasis on scientific evidence generated in Indian patients while evaluating new drugs. Even in cases where there is an unmet medical need, approvals are being recommended with conditions such as Phase IV studies. Where adequate Indian clinical data is lacking, companies are being asked to generate additional evidence before their products can be approved.
